Peripheral Artery DiseaseNCT02778568
Acute Cardiovascular Responses and Chronic Adaptations of Strength Exercise in Intermittent Claudication Patients
A study testing Resistance training in people with Peripheral Artery Disease and Intermittent Claudication, run by University of Pernambuco at 1 site in Brazil.
Trial summary
The aim of this study was to analyze the effects of resistance exercise and training on cardiovascular function of peripheral artery disease patients. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Peripheral Artery Disease, Intermittent Claudication
- What is being tested?
- Resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Had a graded treadmill test that was limited by claudication (2 minutes)
- Had an ankle brachial index <0.90
- Had systolic blood pressure ,160 mmHg and/or diastolic blood pressure,105 mmHg
- Were not performing any regular exercise program
- Were not using antihypertensive medications affecting the heart rate (e.g., b-blockers and nondihydropyridine calcium channel blockers)
- Were nonobese
- Individuals who have not undergone bypass surgery or angioplasty least one year ago
Who cannot join
- Had no symptoms related to myocardial ischemia during the treadmill test
- Amputation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Emergency Hospital of Pernambuco - PROCAPE
Recife, Pernambuco, 50100-060
About this study
The aim of this study was to analyze the effects of resistance exercise and training on cardiovascular function of peripheral artery disease patients.
Read the detailed description
Several studies have shown that strength training can promote important benefits for the cardiovascular system in healthy subjects and patients with chronic diseases. However, the effects of resistance exercise on cardiovascular function in intermittent claudication patients are unclear. In addition, it also do not know the chronic effects on cardiovascular function in these patients.
- Being tested
- Resistance training, Control
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
Also called Physical training
Resistance training exercises
ControlBehavioural
Stretching exercises
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training | Experimental | Patients performed resistance exercises Receives: Behavioral: Resistance training |
| Control | Active comparator | Patients who performed flexibility exercise Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Measured: Change from baseline to 12 and 24 weeks
Secondary outcomes (8)
Change in Walking distance
Measured: Change from baseline to 12 and 24 weeks
Change in Health related Quality of life
Measured: Change from baseline to 12 and 24 weeksBaseline, 12 wks and 24 wks
Change in Muscle blood flow of limbs
Muscle blood flow assessed with venous occlusion plethysmography
Measured: Change from baseline to 12 and 24 weeks
Change in body fat
Measured: Change from baseline to 12 and 24 weeks
Change Serum Cholesterol
Measured: Change from baseline to 12 and 24 weeks
Change in serum glucose
Measured: Change from baseline to 12 and 24 weeks
Change in TNFalpha
Measured: Change from baseline to 12 and 24 weeks
Change in Score Short-physical performance battery
Measured: Change from baseline to 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startJan 2010
- Primary completionDec 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pernambuco
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Ciência e Tecnologia de Pernambuco, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Raphael M. Ritti Dias, University of Pernambuco
- Investigators
- Marilia A Correia, MS, Study chair, University of Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778568
- Sponsor's protocol ID
- RMR2013FCPE MOVED
- Status last verified
- May 2016
- First submitted
- 12 Dec 2013
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cardiovascular Responses and Chronic Adaptations of Strength Exercise in Intermittent Claudication Patients
- ClinicalTrials.gov ID
- NCT02778568
- Acronym / sponsor ID
- RMR2013FCPE MOVED
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PernambucoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Ciência e Tecnologia de Pernambuco, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jan 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to analyze the effects of resistance exercise and training on cardiovascular function of peripheral artery disease patients.
Detailed description
Several studies have shown that strength training can promote important benefits for the cardiovascular system in healthy subjects and patients with chronic diseases. However, the effects of resistance exercise on cardiovascular function in intermittent claudication patients are unclear. In addition, it also do not know the chronic effects on cardiovascular function in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Training | Experimental | Behavioral: Resistance trainingPatients performed resistance exercises |
| Control | Active comparator | Behavioral: ControlPatients who performed flexibility exercise |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Had a graded treadmill test that was limited by claudication (2 minutes)
- Had an ankle brachial index <0.90
- Had systolic blood pressure ,160 mmHg and/or diastolic blood pressure,105 mmHg
- Were not performing any regular exercise program
- Were not using antihypertensive medications affecting the heart rate (e.g., b-blockers and nondihydropyridine calcium channel blockers)
Key exclusion criteria (2 listed)
- Had no symptoms related to myocardial ischemia during the treadmill test
- Amputation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance trainingAlso: Physical trainingResistance training exercises | Behavioural | Resistance Training |
| ControlStretching exercises | Behavioural | Control |
Primary outcome
Change in blood pressure
Time frame: Change from baseline to 12 and 24 weeks
8 secondary outcomes
Change in Walking distance
Time frame: Change from baseline to 12 and 24 weeks
Change in Health related Quality of life
Time frame: Change from baseline to 12 and 24 weeksBaseline, 12 wks and 24 wks
Change in Muscle blood flow of limbs
Time frame: Change from baseline to 12 and 24 weeks
Change in body fat
Time frame: Change from baseline to 12 and 24 weeks
Change Serum Cholesterol
Time frame: Change from baseline to 12 and 24 weeks
Change in serum glucose
Time frame: Change from baseline to 12 and 24 weeks
Change in TNFalpha
Time frame: Change from baseline to 12 and 24 weeks
Change in Score Short-physical performance battery
Time frame: Change from baseline to 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilia A Correia, MS study chair
University of Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Peripheral Artery Disease and Intermittent Claudication, run by University of Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure (time frame: Change from baseline to 12 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2016.